The present invention relates to an auditory ossicle prosthesis designed for replacing or bridging at least one element in the human auditory ossicle chain with a sound transmitting prosthesis body which at one end has a first coupling element designed as a head plate for mechanical connection of the prosthesis to the tympanic membrane and which at the other end has a second coupling element either designed for mechanical connection of the prosthesis to a second element of the human auditory ossicle chain, in particular to the stapes footplate, or for being inserted directly into the inner ear, whereby a stabiliser element is provided which is designed for fixation of the auditory ossicle prosthesis in its implanted state on a level with the plane of the tympanic membrane and for stabilising the position of the implanted auditory ossicle prosthesis in the middle ear, whereby the stabiliser element is adapted for permanent and stable securing at a section of the prosthesis body adjacent to the first coupling element and comprises a fixation part for anchoring the stabiliser element at one or more places of the ear canal wall.
Devices of this type are described in EP 0 231 162 A1, U.S. Pat. No. 4,130,905, WO 2010/150016 A1 and DE 20 2008 003887 U1.
Similar devices are, for example, described in DE 10 2007 041 539 B4 or US 2009 149 697 A1.
Ossicle prostheses are used in cases in which the ossicles of the human middle ear are missing or damaged, either entirely or partially, to conduct sound from the tympanic membrane to the inner ear. The ossicle prosthesis has two ends. Depending on the specific circumstances, one end of the ossicle prosthesis is fastened to the tympanic membrane, for instance, using a top plate, and the other end of the ossicle prosthesis is fastened, e.g., to the stapes of the human ossicular chain, or it is inserted directly into the inner ear. In many cases, with the known ossicle prostheses, sound conduction between the tympanic membrane and the inner ear is limited, because most known ossicle prostheses do not fully replace the natural anatomical formations of the ossicular chain.
After the prosthesis has been surgically implanted in the middle ear and the tympanic membrane has been closed, the recovery phase begins. Scars form during this period, and they produce unforeseeable forces, which can cause the prosthesis to move out of its initially localized position within the middle ear.
U.S. Pat. No. 4,169,292 A describes a—comparatively exotic—artificial middle ear prosthesis for replacing the complete ear structure from the bony ear canal up to the oval window of the vestibule including a tube to replace at least part of the bony ear canal, an annulus to connect an artificial ear drum to the tube, a complex structure to replace the hammer and anvil of a human patient and a piston means connected to the complex structure to replace at least part of the stirrup. This very complex type of middle ear prostheses requires, however, very extensive operational effort for being implanted, in particular the provision of an artificial ear canal. On the other hand does this type of prostheses not allow for being directly mechanically coupled to the tympanic membrane or anyone of the ossicles.